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ACLARO PD HYDROQUINONE
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DescriptionHydroquinone is 1,4-benzenediol. Hydroquinone is structurally
related to monobenzone. Hydroquinone occurs as fine, white needles. The drug is
freely soluble in water and in alcohol with a pKa of 9.96. Chemically, hydroquinone
is designated as p–dihydroxybenzene; the empirical formula is C6H6O2; molecular
weight 110.1. The structural formula is:
ACTIVE INGREDIENT: hydroquinone USP 4%.
Other Ingredients: ascorbic acid, benzyl alcohol, butyl methoxydibensoyl
methane, C12-15 alkyl benzoate, cetearyl ethylhexanoate, cetyl alcohol, cetyl esters,
cetyl palmitate, DEA – cetyl phosphate, dimethicone, dimethylacrylamide/
acrylic acid/polystyrene ethyl methacrylate copolymer, disodium EDTA, ethylhexyl
methoxycinnamate, glycerine, glycolic acid, hydroxyl ethyl cellulose, phenoxyethanol,
propylene glycol (and) BHA (and) citric acid, purified water, sodium hydroxide solution,
Clinical PharmacologyTopical application of hydroquinone produces a reversible
depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to
3-(3,4-dihydroxyphenyl) alanine (dopa)1 and suppression of other melanocyte metabolic
Indications and UsageAclaro PD® is indicated for the gradual treatment of ultraviolet induced dyschromia and
discoloration resulting from the use of oral contraceptives, pregnancy, hormone
replacement therapy, or skin trauma.
Aclaro PD® is contraindicated in any patient that has a
WarningsA. Caution: Hydroquinone is a depigmenting agent which may produce unwanted
cosmetic effects if not used as directed. The physician should be familiar with the
contents of this insert before prescribing or dispensing this medication.
B.Test for skin sensitivity before using Aclaro PD® (hydroquinone USP 4%)
bioadhesive emulsion by applying a small amount to an unbroken patch of skin and
check within 24 hours. Minor redness is not a contraindication, but where there
is itching, vesicle formation, or excessive inflammatory response, further treatment
is not advised. Close patient supervision is recommended. Contact with the eyes
should be avoided. If no lightening effect is noted after two months of treatment, use
of Aclaro PD® bioadhesive emulsion should be discontinued.
C. Sunscreen use is an essential aspect of hydroquinone therapy because even
minimal sunlight exposure sustains melanocyte activity. The sunscreens in
Aclaro PD® bioadhesive emulsion provide the necessary sun protection during
therapy. During and after the use of Aclaro PD® bioadhesive emulsion, sun exposure
should be limited or sun-protective clothing should be used to cover the treated areas
to prevent repigmentation.
D. Keep this and all medications out of the reach of children. In case of accidental
ingestion, contact a physician or poison control center immediately.
E. On rare occasions, a gradual blue-black darkening of the skin may occur. If this
occurs, the product should be discontinued and a physician contacted immediately.
A. Pregnancy Category C: Animal reproduction studies have not been conducted with
B. Nursing mothers: It is not known whether topical hydroquinone is absorbed or
C. Pediatric usage: Safety and effectiveness
Adverse ReactionsNo systemic reactions have been reported. Occasional
cutaneous hypersensitivity (localized contact dermatitis) may occur, in which
case the medication should be discontinued and the physician notified immediately.
There have been no systemic reactions reported from the use of topical
Dosage and Administration
Aclaro PD® (hydroquinone USP 4%)bioadhesive emulsion is available in a:
Store at controlled room temperature: 15˚-30˚ C (59˚–86˚ F)
Manufactured for: Innocutis
a JSJ Pharmaceuticals company
Charleston, SC 29401
Toll free: 1-800-499-4468
U.S. Pat. No.: 5,942,243
Revised: 04/2011 JSJ Pharmaceuticals
Reproduced with permission of U.S. National Library of Medicine
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